1. Horizon 2020 Ian Devine European Advisor – UK Research Office University of Manchester, 11 September 2014

2.  Ethics in Horizon 2020  Proposal and Evaluation Stage  Grant Preparation and Implementation  Resources

3. Horizon 2020

4.  Ethics is a consideration for all EU funded projects in all research domains  Ethics are integral to all research, from beginning to end  Considering ethics: Ensures it is within the legal framework Enhances the quality of research  Strong connection between research ethics and human rights  Ethics process for Horizon 2020 – Ethics Appraisal Procedure

5. “In addition to the scientific evaluation focusing on the scientific merit, the quality of the management and the potential impact, the Ethics Appraisal ensures that all research activities carried out under the Horizon 2020 Framework Programme are conducted in compliance with fundamental ethical principles.”

6.  Art 19: Ethical Principles (mentioned throughout, but in particular) “All the research and innovation activities carried out under Horizon 2020 shall comply with ethical principles and relevant national, Union and international legislation, including the Charter of Fundamental Rights of the European Union and the European Convention on Human Rights and its Supplementary Protocols.”Charter of Fundamental Rights of the European Union http://ec.europa.eu/research/participants/data/ref/h202 0/legal_basis/fp/h2020-eu-establact_en.pdf

7.  Respect human dignity and integrity  Ensuring honesty and transparency towards research subjects - free and informed consent (as well as assent whenever relevant)  Protect vulnerable persons  Ensure privacy and confidentiality  Promote justice and inclusiveness  Minimise harm and maximising benefit  Share benefits with disadvantaged populations, especially if the research is being carried out in developing countries  Maximise animal welfare - in particular by ensuring replacement, reduction and refinement (‘3Rs’) in animal research  Respect and protect the environment and future generations  Follow highest standards of research integrity (i.e. avoid fabrication, falsification, plagiarism, double funding, etc.)

8.  Art 19.3: The following areas will not be funded: A) Research activity aiming at human cloning for reproductive purposes; B) Research intended to modify the genetic heritage of human beings which could make such changes heritable; C) Research activities intended to create human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer.

9.  Art 19.4: Human Stem Cells “Research on human stem cells, both adult and embryonic, may be financed, depending both on the contents of the scientific proposal and the legal framework of the Member States involved. No funding shall be granted for research activities that are prohibited in all the Member States. No activity shall be funded in a Member State where such activity is forbidden.”

10. Ethics covered throughout, but in particular:  Art 13.3: Proposals contravening ethical principles/legislation may be excluded  Art 14: Ethics Review of proposals raising ethical concerns http://ec.europa.eu/research/participants/data/ref/h2020/legal_b asis/rules_participation/h2020-rules-participation_en.pdf

11. Source: European Commission 3 Main Steps

12. Horizon 2020

13.  Applicants should proactively demonstrate that all ethical issues have been considered  Applications should be ‘Ethics Ready’

14.  Section 4 ‘Ethics Issues Table’ – 10 Questions: 1.Human embryo/foetuses 2.Humans 3.Human cells/tissues 4.Protection of personal data 5.Animals 6.Non-EU countries 7.Environment protection 8.Dual-use (military application?) 9.Misuse 10.Other ethics issues

15.  Section 4 ‘Ethics Issues Table’ – 10 Questions If ‘yes’ for any questions, ethic-self assessment to be completed in Part B

16.  Section 5 ‘Ethics and Security’ To be completed if ‘yes’ for any questions in ethics issues table part A Provide appropriate documents as evidence

17.  In addition to their scientific merit, all applications are evaluated on their ethical and social impact  All proposals retained with a view to funding undergo an Ethics Review: 1) Ethics screening 2) Ethics assessment (if appropriate/recommended)

18.  Conducted during scientific evaluation (or soon after)  Application’s self-assessment considered  Particular attention paid to proposal’s: Objectives; Methodology; Potential impact.  Proposals requiring ethical approval at national level identified  Experts may recommend Ethics Assessment due to the complexity or the nature of the ethical issues All proposals involving use of Human Embryonic Stems Cells (hESCs) will automatically go to an Ethics Assessment

19.  In-depth analysis of the ethical issues –Ethics Screening conclusions considered if available  Only conducted when appropriate/recommended  Limited number of proposals: Severe intervention on humans; Lack of appropriate ethics framework in the country where the research will be performed; Automatically for proposals involving Human Embryonic Stems Cells (hESCs).  Ethics screening and assessment normally occurs prior to the signing of the grant agreement

20.  Each proposal at least 3 expert evaluators  European Commission appoints a pool of ethics experts annually  Ethics experts invited to comment on proposals depending on: Their relative skills/expertise Nature of proposals Ethical issues to be considered  When the above conditions are met, also consider: Appropriate geographical/gender balance Regular rotation of experts

21. Horizon 2020

22.  The Ethics Screening or Ethics Assessment can highlight an ‘Ethics Check’ indicating areas of a project to be monitored  Helps beneficiaries deal with ethical issues taking preventative/corrective measures if appropriate  On-site visits or trips to Brussels to discuss progress and ethical issues possible

23.  If ethical principles substantially breached, ‘Ethics Audit’ can be conducted  If ethical breach considered severe: Grant Agreement may be amended; Grant may be reduced; Grant may be terminated; Other appropriate measures (in accordance with Grant Agreement).

24.  Ethics considered through Grant Agreement  Art 34: ‘Ethics’ Must comply with ethical principles Must comply with international, European and national law Activity outside EU prohibit in EU cannot be funded Must comply with ‘ethical requirements’ agreed in annex 1 Before beginning an activity with ethical implication, must provide relevant approval (if not in English, a summary in English is to be provided) Grant can be reduced/terminated if breached – legal action may also be taken

25.  Art 22: Ethics checks, reviews and audits “The Commission [or the Agency] will — during the implementation of the action or afterwards — check the proper implementation of the action and compliance with the obligations under the Agreement, including assessing deliverables and reports.” Where appropriate and in the Grant Agreement, periodic checks, reviews and audits of ethics will be conducted, which can occur during or up to 2 years after completion of the project

26. Horizon 2020

28.  Ethics Helpdesk http://ec.europa.eu/research/participants/portal/desktop/e n/support/other_help_services.html#ohs4

29.  Ethics Issues Table template http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual /hi/ethics/ethics-eit_en.pdf http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual /hi/ethics/ethics-eit_en.pdf  How to complete your ethics self-assessment http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual /hi/ethics/h2020_hi_ethics-self-assess_en.pdf http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual /hi/ethics/h2020_hi_ethics-self-assess_en.pdf  Horizon 2020 Online Manual – Ethics http://ec.europa.eu/research/participants/docs/h2020-funding- guide/cross-cutting-issues/ethics_en.htm http://ec.europa.eu/research/participants/docs/h2020-funding- guide/cross-cutting-issues/ethics_en.htm  Ethics for researchers http://ec.europa.eu/research/participants/data/ref/fp7/89888/ethics-for- researchers_en.pdf http://ec.europa.eu/research/participants/data/ref/fp7/89888/ethics-for- researchers_en.pdf  Strategy to minimize ethical misconduct http://ec.europa.eu/research/participants/data/ref/fp7/89797/improper- use_en.pdf http://ec.europa.eu/research/participants/data/ref/fp7/89797/improper- use_en.pdf  Textbook on ethics in research http://ec.europa.eu/research/science- society/document_library/pdf_06/textbook-on-ethics-report_en.pdfhttp://ec.europa.eu/research/science- society/document_library/pdf_06/textbook-on-ethics-report_en.pdf

30. Ian.Devine@BBSRC.ac.uk